By Rubén Gómez Rioja ORCID logo, Débora Martínez Espartosa, Marta Segovia, Mercedes Ibarz ORCID logo, María Antonia Llopis, Josep Miquel Bauça, Itziar Marzana, Nuria Barba, Monserrat Ventura, Isabel García del Pino, Juan José Puente, Andrea Caballero, Carolina Gómez, Ana García Álvarez, María Jesús Alsina and Virtudes Álvarez
Published on: May 5, 2018
Background: The stability limit of an analyte in a biological sample can be defined as the time required until a measured property acquires a bias higher than a defined specification. Many studies assessing stability and presenting recommendations of stability limits are available, but differences among them are frequent. The aim of this study was to classify and to grade a set of bibliographic studies on the stability of five common blood measurands and subsequently generate a consensus stability function.
Methods: First, a bibliographic search was made for stability studies for five analytes in blood: alanine aminotransferase (ALT), glucose, phosphorus, potassium and prostate specific antigen (PSA). The quality of every study was evaluated using an in-house grading tool. Second, the different conditions of stability were uniformly defined and the percent deviation (PD%) over time for each analyte and condition were scattered while unifying studies with similar conditions.
Results: From the 37 articles considered as valid, up to 130 experiments were evaluated and 629 PD% data were included (106 for ALT, 180 for glucose, 113 for phosphorus, 145 for potassium and 85 for PSA). Consensus stability equations were established for glucose, potassium, phosphorus and PSA, but not for ALT.
Conclusions: Time is the main variable affecting stability in medical laboratory samples. Bibliographic studies differ in recommendations of stability limits mainly because of different specifications for maximum allowable error. Definition of a consensus stability function in specific conditions can help laboratories define stability limits using their own quality specifications.